[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587467":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":76,"collaborators":47,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":47,"enrollmentInfo":89,"targetDuration":47,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":102,"whyStopped":47,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Flinders University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Eszopiclone 3mg and lemborexant 10mg","EXPERIMENTAL","Both Eszopiclone 3mg and Lemborexant 10mg in the form of capsules taken before bedtime. Dosages is taken on one instance for one night only.",[13,14],"Drug: Eszopiclone 3 mg","Drug: Lemborexant 10mg",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","Placebo capsules that look exactly like the study drugs, taken before bedtime. Dosage is taken on one instance for one night only.",[20],"Drug: Placebo",[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Eszopiclone 3 mg","Both eszopiclone and lemborexant taken together at bedtime for one night",[9],[28],"Lunesta",{"type":23,"name":16,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo sugar pills that looks like the eszopiclone and lemborexant capsules taken at bedtime for one night.",[16],[33],"Sugar pill",{"type":23,"name":35,"description":25,"armGroupLabels":36,"otherNames":37},"Lemborexant 10mg",[9],[38],"Dayvigo",[40],{"name":41,"affiliation":5,"role":42},"Danny J Eckert, PhD","PRINCIPAL_INVESTIGATOR",[44,49],{"name":41,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","+61 8 7421 9780",null,"danny.eckert@flinders.edu.au",{"name":50,"role":45,"phone":51,"phoneExt":47,"email":52},"Cricket SB Fauska, BA","+61 8 8201-2706","cricket.fauska@flinders.edu.au",[54],{"facility":55,"status":47,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Flinders University, Adelaide Institute for Sleep Health","Bedford Park","South Australia","5042","Australia","AU",{"type":62,"coordinates":63},"Point",[64,65],138.56815,-35.02204,{"lat":65,"lon":64},[68,72],{"name":69,"role":45,"phone":70,"phoneExt":47,"email":71},"Laboratory Deputy Manager \u002F Clinical Trials Coordinator","+61 8 8201 7781","aish.sleeplab@flinders.edu.au",{"name":73,"role":45,"phone":74,"phoneExt":47,"email":75},"Charmaine O'Reilly","+61 8 8201 3177","charmaine.oreilly@flinders.edu.au",{"type":42,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Professor Danny Eckert","Director, Adelaide Institute for Sleep Health, Professor, College of Medicine and Public Health and Matthew Flinders Fellow, Flinders University","100587467","phase-2-effects-of-eszopiclone-and-lemborexant-in-people-with-osa-with-a-low-arousal-threshold-who-have-difficulty-sleeping-100587467",false,"NCT06928766","Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping","Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea (OSA) With a Low Arousal Threshold Who Have Difficulty Maintaining or Falling Asleep (ELOSA): A Double-blind, Placebo-controlled, Randomised, Trial.","ELOSA","Inclusion Criteria:\n\n* Moderate or more difficulty \"staying or initiating asleep\" score on the Insomnia Severity Index questionnaire\n* Obstructive Sleep Apnoea (OSA), Apnoea Hypopnea Index ≥ 10 events\u002Fhour\n* Low arousal respiratory threshold OSA endotype\n* BMI ≤35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Concomitant medications that interact or are contraindicated with eszopiclone, zopiclone, and Lemborexant\n* Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology\n* Current pregnancy or breast-feeding\n* Current or recent other medical conditions likely to affect results or safety","ALL","18 Years",{"count":90,"type":91},15,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","Insomnia and obstructive sleep apnoea (OSA) are very common conditions, collectively estimated to affect 2 billion people globally, and share many of the same symptoms. It is also common for people to have both insomnia and sleep apnoea (COMISA). Indeed, 30 to 40% of patients with chronic insomnia also fulfil the diagnostic criteria for OSA. These people can be particularly challenging to treat with conventional therapy approaches.\n\nPeople get OSA for different reasons. One key cause is waking up too easily to minor airway narrowing episodes (a low arousal threshold).\n\nAccordingly, this study aims to increase the arousal threshold using a combination approach with a GABAergic and an orexin agent in appropriately selected individuals (i.e., the clinically relevant group of people with OSA with a low arousal threshold and difficulty maintain or initiating sleep). Sleep, breathing and next day performance will be compared across two monitored overnight sleep studies (placebo vs the study drugs).",[97],"OSA - Obstructive Sleep Apnea",[99,100,101],"sleep disordered breathing","arousal","COMISA","NOT_YET_RECRUITING","2025-04-15",{"date":105,"type":106},"2025-04-18","ACTUAL",{"date":108,"type":91},"2025-05-01",{"date":110,"type":91},"2027-06-30",{"name":5,"class":6},1]